OpenRegulatory Conference 2021
Ivo Flipse, Zimmer Biomet
Software Requirements Management
By storing your requirements and specifications in text-based files, you can generate up to date documentation, produce flawless trace matrices, leverage version control software during change management and integrate nicely into the software development workflow.
Ivo is Project Manager at Zimmer Biomet where he works on preoperative hip planning software since 2014. Through trial and even more error he has gained a lot of experience in how to avoid the pitfalls of developing SaMD. Resulting in two successful 510k submissions and several audits without (major) findings.